PL3716951T3 - Process and device for preparing a solid dispersion - Google Patents

Process and device for preparing a solid dispersion

Info

Publication number
PL3716951T3
PL3716951T3 PL18811797T PL18811797T PL3716951T3 PL 3716951 T3 PL3716951 T3 PL 3716951T3 PL 18811797 T PL18811797 T PL 18811797T PL 18811797 T PL18811797 T PL 18811797T PL 3716951 T3 PL3716951 T3 PL 3716951T3
Authority
PL
Poland
Prior art keywords
preparing
solid dispersion
dispersion
solid
Prior art date
Application number
PL18811797T
Other languages
Polish (pl)
Inventor
Tiziana Adage
Original Assignee
Bit Pharma Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bit Pharma Gmbh filed Critical Bit Pharma Gmbh
Publication of PL3716951T3 publication Critical patent/PL3716951T3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A61K9/204—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/022—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the choice of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B29K2067/04—Polyesters derived from hydroxycarboxylic acids
    • B29K2067/043—PGA, i.e. polyglycolic acid or polyglycolide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B29K2067/04—Polyesters derived from hydroxycarboxylic acids
    • B29K2067/046—PLA, i.e. polylactic acid or polylactide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
    • B29K2105/0035—Medical or pharmaceutical agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)
PL18811797T 2017-11-30 2018-11-29 Process and device for preparing a solid dispersion PL3716951T3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17204645.0A EP3492070A1 (en) 2017-11-30 2017-11-30 Process and device for preparing a solid dispersion
EP18811797.2A EP3716951B1 (en) 2017-11-30 2018-11-29 Process and device for preparing a solid dispersion
PCT/EP2018/083009 WO2019106090A1 (en) 2017-11-30 2018-11-29 Process and device for preparing a solid dispersion

Publications (1)

Publication Number Publication Date
PL3716951T3 true PL3716951T3 (en) 2022-06-06

Family

ID=60811754

Family Applications (1)

Application Number Title Priority Date Filing Date
PL18811797T PL3716951T3 (en) 2017-11-30 2018-11-29 Process and device for preparing a solid dispersion

Country Status (17)

Country Link
US (1) US11413247B2 (en)
EP (2) EP3492070A1 (en)
JP (1) JP7250029B2 (en)
CN (1) CN111405894A (en)
AU (1) AU2018376566B2 (en)
BR (1) BR112020008646A2 (en)
CL (1) CL2020001176A1 (en)
DK (1) DK3716951T3 (en)
ES (1) ES2910012T3 (en)
HU (1) HUE058088T2 (en)
IL (1) IL274348A (en)
MX (1) MX2020004589A (en)
PL (1) PL3716951T3 (en)
PT (1) PT3716951T (en)
SG (1) SG11202004062WA (en)
SI (1) SI3716951T1 (en)
WO (1) WO2019106090A1 (en)

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3024416C2 (en) * 1980-06-28 1982-04-15 Gödecke AG, 1000 Berlin Process for the production of medicaments with sustained release of active substances
ES2086229T3 (en) * 1992-05-22 1996-06-16 Goedecke Ag PROCEDURE FOR OBTAINING DELAYED ACTION MEDICINAL PREPARATIONS.
DE19721467A1 (en) 1997-05-22 1998-11-26 Basf Ag Process for the preparation of small-scale preparations of biologically active substances
JP2001520984A (en) 1997-10-27 2001-11-06 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング Solid-state solvents and solid dispersions of poorly water-soluble drugs
JPH11286439A (en) * 1998-04-01 1999-10-19 Senju Pharmaceut Co Ltd Biodegradable polymer-type drug release system
US6455526B1 (en) * 1998-12-16 2002-09-24 Aventis Pharmaceuticals, Inc. Biodegradable polymer encapsulated pharmaceutical compositions and method for preparing the same
ATE369122T1 (en) 2001-05-23 2007-08-15 Hexal Ag METHOD FOR PRODUCING IMPLANTS USING SOLVENT-FREE PRODUCTION OF A HOMOGENISATE
BRPI0407181A (en) 2003-02-03 2006-02-07 Novartis Ag Pharmaceutical Formulation
JP5538718B2 (en) 2005-08-08 2014-07-02 アボット ゲーエムベーハー ウント コンパニー カーゲー Itraconazole composition with improved bioavailability
WO2008133102A1 (en) 2007-04-20 2008-11-06 Daido Chemical Corporation Novel base for dry solid dispersion, solid dispersion containing the base, and composition containing the dispersion
US8486423B2 (en) 2007-08-21 2013-07-16 Board Of Regents, The University Of Texas System Thermo-kinetic mixing for pharmaceutical applications
CN101254180B (en) * 2008-03-28 2010-11-10 辽宁正鑫药物研究有限公司 Nimodipine capsule containing semi-solid combination and preparation
EP2140861A1 (en) 2008-06-30 2010-01-06 Abbott GmbH & Co. KG Pharmaceutical dosage form comprising polymeric carrier composition
EP2308478A1 (en) * 2009-10-06 2011-04-13 Abbott GmbH & Co. KG Delivery system for sustained release of a calcium-channel blocking agent
FR2999081B1 (en) 2012-12-06 2015-02-27 Hra Pharma Lab SOLID DISPERSION OF A SELECTIVE PROGESTERONE RECEPTOR MODULATOR
CN103006568A (en) * 2013-01-05 2013-04-03 中国科学院苏州纳米技术与纳米仿生研究所 Felodipine solid dispersion (SD) and preparation method thereof
CN106793821B (en) 2014-08-29 2021-05-07 花王株式会社 Method for producing solid dispersion containing hardly soluble polyphenol
JP6972623B2 (en) 2016-04-26 2021-11-24 三菱ケミカル株式会社 Base for solid dispersion, method for producing solid dispersion using it, and solid dispersion

Also Published As

Publication number Publication date
CN111405894A (en) 2020-07-10
US20200368165A1 (en) 2020-11-26
HUE058088T2 (en) 2022-06-28
SI3716951T1 (en) 2022-06-30
CL2020001176A1 (en) 2020-10-30
AU2018376566B2 (en) 2023-11-30
BR112020008646A2 (en) 2020-10-27
ES2910012T3 (en) 2022-05-11
US11413247B2 (en) 2022-08-16
PT3716951T (en) 2022-04-06
EP3716951A1 (en) 2020-10-07
IL274348A (en) 2020-06-30
EP3716951B1 (en) 2022-01-05
JP2021504487A (en) 2021-02-15
AU2018376566A1 (en) 2020-04-23
JP7250029B2 (en) 2023-03-31
DK3716951T3 (en) 2022-04-04
RU2020121500A (en) 2021-12-30
MX2020004589A (en) 2022-08-11
WO2019106090A1 (en) 2019-06-06
SG11202004062WA (en) 2020-06-29
EP3492070A1 (en) 2019-06-05
RU2020121500A3 (en) 2022-04-05

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